Drill bit data management for penetration-monitoring drill

ABSTRACT

Embodiments directed to an apparatus and system of monitoring an instrument with a working tool engaged thereby. In one aspect, an embodiment including a working tool with a machine readable indicium indicative of a working tool attribute. The working tool may be receivable by an instrument such that a corresponding machine readable indicia reader receives an identifier of the working tool. Various attributes and conditions in relation to the instrument and working tool received thereby may be identified to facilitate the provisioning of a response to prompt various corrective actions. In this regard, a controller may provide an output in response to a received identifier of a working tool and an identified instrument operating condition.

FIELD

The present invention generally relates to powered surgical instruments,and in particular to powered surgical instruments that releasably engagea working tool to perform an operation.

BACKGROUND

Various powered surgical instruments (e.g., drills, saws, grinders,etc.) may be associable with a plurality of corresponding working tools(e.g., drills bits, saw blades, grinding burrs, etc.) to facilitatecertain operations using the powered surgical instruments. For example,a handheld drill may engage any one of a plurality of drill bits inorder to bore a hole through a medium of interest such as an anatomicalstructure of a patient. Further, in such settings, each of the pluralityof working tools may embody certain attributes including but not limitedto a certain size, serial number, material composition, manufacturer,temperature tolerance, and the like. For example, a first respectivedrill bit may constitute a first bore diameter and a first material madeby a first manufacturer, while a second respective drill bit mayconstitute a second bore diameter and a second material made by a secondmanufacturer. In this regard, the operation of the instrument includingthe functionality, specifications, and limitations related thereto maybe at least partially based on the particular respective working toolengaged by the powered surgical instrument. That is, the specificattributes of the engaged working tool may at least partially inform orotherwise impact the functionality of the instrument, for example, bydefining the operational limitations of the instrument in relation tothe engaged working tool. In this regard, the first respective drill bitwith the first bore diameter and first material may limit the rotationalspeed, for example, at which the instrument may be used to bore a hole,etc.

Further, some electro-mechanical instruments may include one or moresensors integrated therein to measure various conditions of theinstrument and/or of the operational environment thereof such as thedensity of a medium through which a working tool is advanced during use.In this regard, in such circumstances, the values measured by the one ormore sensors of the instrument and any outputs related thereto may be atleast partially based on the particular engaged working tool and itsassociated attributes. As such, with regards to the foregoing, it may bedesirable to identify the particular engaged working tool and theattributes related thereto.

SUMMARY

In view of the foregoing, the present disclosure facilitates a systemfor monitoring an instrument and a working tool engaged by theinstrument. The instrument may be a powered surgical instrument and theworking tool may be used in conjunction with the powered surgicalinstrument for performing an operation. The system may facilitategeneration of an output or signal from an indicia reader responsive todetection of an indicium associated a working tool. An indicium may beindicative of or associated with a working tool attribute and/orinstrument operating condition. The invention allows a user of theinstrument to effectively manage a system in which a plurality ofworking tools may be engageable by the instrument so as to identifyrelevant information in relation to a respective working tool engaged bythe instrument. The invention further allows the user to identifyrelevant information in relation to one or more measurable or determinedconditions associated with the instrument that may prompt or otherwisefacilitate corrective or other remedial action.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an embodiment of a monitoring system for monitoring aninstrument and working tool engaged thereby.

FIG. 2 is a functional block diagram of a controller and instrument foruse in a system for monitoring an instrument, according to oneembodiment.

FIG. 3 is a functional block diagram of an access terminal for use in asystem for monitoring an instrument, according to one embodiment.

FIGS. 4 and 5 illustrate various screenshots of embodiments of a userinterface displayable via a portal of a system for monitoring aninstrument.

FIG. 6 illustrates with a flow diagram an embodiment of a method formonitoring an instrument.

FIG. 7 is an elevation view, partially in cross section of an embodimentof a real-time, drill bit penetration measuring system.

FIG. 8A is a sectional view of bone illustrating a prior art method ofusing a drill mechanism to create a bicortical path through a corticalbone having multiple layers.

FIG. 8B is a sectional view of a bone illustrating a prior art method ofusing a drill mechanism to create a unicortical drill path through theouter layer of a cortical bone.

FIG. 9A is an enlarged sectional view of the embodiment of the drill bitload measurement assembly of FIG. 7 .

FIG. 9B is a sectional view of a portion of the drill bit loadmeasurement assembly taken along the line 9 b-9 b of FIG. 9A.

FIG. 10A is an enlarged sectional view of an embodiment of the drill bitload measurement assembly of FIG. 7 .

FIG. 10B is a sectional view of a portion of the drill bit loadmeasurement assembly taken along the line 10 b-10 b of FIG. 10A.

FIG. 11 is an elevation view of an embodiment of a control panel of acontroller assembly of FIG. 7 .

FIG. 12 is a schematic block diagram of the controller assembly of FIG.7 and the inputs and outputs of the controller assembly.

FIGS. 13A, 13B, and 13C are diagrams illustrating the position of thedrill bit of FIG. 7 in bicortical bore of FIG. 8B and the correspondingoutput of the first and second sensors of the displacement and loadmeasurement assemblies of FIG. 2 .

FIG. 14 is a flow diagram of an embodiment of a method for determiningthe depth of penetration of a drill bit.

FIGS. 15A and 15B depict an embodiment of a controller for use inoperation of a drill having a drill bit penetration measurement system.

FIGS. 16A, 16B, and 16C are perspective, side, and front views,respectively, of an embodiment of a drill comprising a drill bitpenetration measurement system.

FIG. 17 is a perspective view with a partial cutaway of a drill body ofan embodiment of a drill comprising a drill bit penetration measuringsystem.

FIG. 18 is a cross sectional schematic view of a drill bit that has beenadvanced into a bore in a medium relative to a bushing engaged with adistal portion of a displacement sensing arm.

DETAILED DESCRIPTION

Disclosed herein are utilities (e.g., systems, processes, etc.) formonitoring an instrument operatively associated with a working tool. Inthis regard, the disclosed utilities include a working tool having amachine readable indicium associated with at least one working toolattribute. The working tool may be receivable by the instrument, forexample, via operation of a chuck or other receiving element operable toreceive or otherwise secure and engage the working tool therein. Uponreceipt of a working tool, a corresponding machine readable indiciareader may analyze the indicium to determine an identifier associatedwith the working tool. The identifier may be used to retrieve a workingtool attribute from a database or may directly convey a working toolattribute. For example, in the former instance, the identifier maycomprise a serial number which may be used to identify working toolattributes. In the latter instance, the identifier may directly indicatea working tool attribute such as a manufacturer thereof. The machinereadable indicia reader may transmit an identifier, the same as ordifferent than the identifier received at the machine readable indiciareader, to a controller for processing. The disclosed utilities may alsoinclude a displacement measuring apparatus (or other appropriatemeasuring apparatus) disposed in corresponding relation to the workingtool to measure displacement of the working tool relative to an axisalong which the working tool may be advanced during use. In someinstances, additional or alternative measuring apparatuses may beprovided, as discussed below. The disclosed utilities may also include acontroller (mentioned above) in operative communication with theinstrument and configured to provide an output responsive to a workingtool attribute received, for example, from a database. The output may bedisplayed to a user on a display monitor or may be transmitted to theinstrument to influence the operation thereof.

Working tool attributes may be utilized in many respects. In some cases,a working tool attribute may be used to maintain an inventory of workingtools. For example, a current inventory present at a hospital or othersite may be automatically maintained wherein a quantity is reduced uponthe reading of an indicium associated with a particular type of workingtool represented by the quantity. As another example, each working toolused during an operation may be entered into a list such that uponcompletion of the operation, personnel may take inventory of workingtools brought into the operating room to verify that all working toolsare accounted for.

Additionally, working tool attributes may be monitored to ensure safeoperation of an instrument. For example, a particular instrument may beprevented from operating unless and until one or more attributes of aworking tool associated therewith have been verified as compliant withrequired specifications. As another example, an instrument may bedisabled upon a determination, based upon an indicium associated withthe working tool, that the working tool is not new from the factory butrather has been used with another patient or has been refurbished by anunlicensed party.

Finally, working tool attributes may be recorded in a database ofsurgical operation statistics to improve medical procedures. Forexample, during an operation, a drill may record operating conditionssuch as force applied, motor speed, and displacement into a patient'sbone. This information may be recorded in conjunction with demographicsabout the patient and attributes associated with the drill bit utilized.In this regard, determinations may be made regarding optimal drill bitsize, materials, and methods of use.

Certain terminology is used in the following description for convenienceonly and should not be considered as limiting. The words “inwardly” and“outwardly” refer to directions toward and away from, respectively, thegeometric center of the systems and designated parts thereof describedherein. The terminology includes the words above specifically mentioned,derivatives thereof and words of similar import.

Additionally, as used in the claims and in the corresponding portion ofthe specification, the word “a” means “at least one,” the word “about”when used in conjunction with a numerical value means a range of valuescorresponding to the numerical value plus or minus ten percent of thenumerical value, and the word “or” has the meaning of a Booleaninclusive “Or.” For example, the phrase “A or B” means “A” alone or “B”alone or both “A” and “B.”

As used herein, the term “instrument” may refer to any tool or device,powered or manually operated, which is configured for use with aremovable and replaceable part referred to herein as a working tool. Forexample, an instrument may be a drill, a saw, a screwdriver, etc. and aworking tool may be a drill bit, a saw blade, a screwdriver bit, etc. Amachine readable indicium may be any device or marking that is capableof being read, interpreted, analyzed, or otherwise received by amachine. For example, a machine readable indicium may be a radiofrequency identification (RFID) tag, a bi-directional sensor, a barcode,a QR code, an alphanumeric identifier, etc. Notably, a machine readableindicium need not be readable by machine only but may also be readableby a user. A machine readable indicia reader may be any deviceconfigured to observe, scan, read, or otherwise detect a machinereadable indicium. For example, a machine readable indicia reader may bean RFID reader, an optical sensor, a laser scanner, camera, etc.

Machine readable indicia may be configured to convey a working toolattribute directly or may convey an identifier which can be used tolook-up working tool attributes from a database stored locally orremotely. For example, a machine readable indicium may convey anidentifier such as a serial number to the machine readable indiciareader. The machine readable indicia reader, or a device in operativecommunication therewith such as a controller, may then reference adatabase to retrieve working tool attributes associated with the serialnumber. Notably, “working tool attributes” as that term is used hereinin reference to information received at a controller or instrument froma database may refer to working tool attributes themselves or may referindications of working tool attributes. To illustrate, a database mayconvey to a controller that a particular identifier sent from thecontroller to the database is associated with a size “3” drill bit. Thenumerical value “3” may then be conveyed to the controller whichreferences a data repository to determine that a size “3” drill bit is 4inches long and has a ⅛″ diameter. In this regard, “3” may be consideredan indication of a working tool attribute rather than a working toolattribute itself. Working tool attributes may include a working toolsize, a working tool serial number or other identifier, a material fromwhich the working tool is constructed, a manufacturer of the workingtool, any prior uses of the working tool, an optimum, maximum, orminimum instrument operating speed associated with the working tool, orany other relevant information concerning the working tool.

The term “identifier” as used herein may refer to any information whichis conveyed by an indicium and useful for determining a working toolattribute. In some instances, an identifier may itself be, or maydirectly convey, a working tool attribute and in other instances, anidentifier may be an alphanumeric sequence with working tool attributesencoded therein. A controller may decipher the identifier to determinethe working tool attributes.

A controller, as that term is used herein, may be any device having orassociated with a processing engine which is operable to monitor aninstrument, display properties associated with the instrument, and/orcontrol operation aspects of the instrument. In some instances, acontroller may be integrated directly into an instrument, it may bedisposed adjacent an instrument and in operative communicationtherewith, or may be disposed remotely and configured for communicationwith the instrument via a wired or wireless network. A controller may beoperable to receive an identifier from a machine readable indicia readerand reference a local or remote database to retrieve working toolattributes associated with the identifier. In response to receivingcertain working tool attributes, a controller may be configured to allowan instrument to operate using the respective working tool or mayprevent the instrument from operating. For example, if a working toolattribute indicates that a working tool has previously been used withanother patient, a controller may prevent a drive motor of theinstrument from receiving control signals, thereby disabling theinstrument. A default status of a drive motor may be set by a controllerto “operative” such that the instrument will work unless and until aworking tool attribute is determined to be unacceptable. Alternatively,a default status of a drive motor may be set by a controller to“inoperative” such that the instrument will not work unless and untilall working tool attributes considered critical are determined to beacceptable. The determination of whether a working tool attribute isacceptable or unacceptable may be executed using a series of rules(discussed below).

Broadly, the disclosed embodiments relate to monitoring an instrumentthat is operatively associable with any one of a plurality of workingtools. This may be desirable, for example, in environments in which eachof a plurality of working tools exhibits different attributes which, inturn, influence the operation or use of the instrument. In this regard,the operative association of one of the plurality of working tools withthe instrument may facilitate reading an indicium disposed at theworking tool and associated with or directly communicating one of theparticular attributes of the working tool. In this regard, the inventionmay be used for identifying a working tool attribute of interest of areceived working tool so that a controller may provide an outputresponsive to the identified working tool attribute of interest. Such anoutput may be a signal to enable or disable the instrument or acomponent thereof, may be a signal to trigger an alarm or alert to theuser, for example, indicating that the working tool may be undesirablefor the instant operation, or may affect an operating condition of theinstrument. For example, a working tool attribute indicating a maximumdrive speed of 100 RPM may result in the controller outputting a signalthat limits the drive motor in the instrument to 100 RPM. A working toolattribute may be received or selected at a controller by referencing adatabase using the identifier transmitted by the machine readableindicia reader. For example, the machine readable indicium may bedisposed in proximal relation to the machine readable indicia readersuch that the machine readable indicia reader transmits an identifiercorresponding to the indicium. In this regard, as each working tool mayinclude a respective machine readable indicium, the controller mayprovide an output responsive to characteristics or properties of therespective working tool received at the instrument.

In certain other embodiments, described below, the disclosed utilitiesalso include a data collection module operatively associated with adisplacement measuring apparatus for identifying an instrument operatingcondition. “Instrument operating condition” may refer to a conditioncorresponding to the operation of the instrument itself, the operatingenvironment of the instrument, and/or any other conditions or parametersof interest that may facilitate monitoring an instrument, according tothe embodiments described herein. For example, the data collectionmodule may include or utilize a processor for identifying an instrumentoperating condition at least partially based on a measured displacementof the working tool. For example, the present invention may determine acondition corresponding to the operating condition of the instrument,such as the density of an environment through which the working tool isadvanced during use. Such a determination may be made based upon ameasured force applied to the working tool, the displacement of theworking tool, and working tool attributes.

In other embodiments, a processor may identify an instrument operatingcondition at least partially based on a working tool attribute receivedby the instrument or controller. For example, by receiving a knownweight of the working tool, the processor may be able to determine amagnitude of torque being applied to the working tool by the instrument.

In some instances, the instrument operating condition may facilitatemonitoring an inventory level of working tools that are associable withthe instrument. This may occur, for example, by counting the instancesof a working tool attribute received which correspond to unique workingtools over a period of time and correlating the received working toolattributes to determine an inventory level. For example, a database maybe used to store a dynamic count of each time a working tool is usedhaving a particular attribute, such as a ⅜″ diameter. In this regard,the count may be increased by manual or automatic entry of a quantity ofworking tools received in a delivery and may be decreased by one eachtime a uniquely identified working tool having the attribute of interestis used.

It should be appreciated, however, that alternative or additionalmeasuring apparatus embodiments may be utilized in accordance with thepresent invention, which may be used to identify the instrumentoperating condition or provide other information of interest. Forexample, in addition or in the alternative to the disclosed displacementmeasuring apparatus, the instrument may include a rotational measuringapparatus disposed in corresponding relation to the working tool tomeasure rotational characteristics of the instrument such as angularvelocity, angular frequency, torque, etc. A processor may obtainmeasured rotational characteristics of the instrument for identifying aninstrument operating condition. As another example, the instrument mayinclude a power systems measuring apparatus disposed in correspondingrelation to a drive mechanism of the instrument to measurecharacteristics in relation to the operation of the working tool such asvoltage and current fluctuations, powers, resistance, efficiency,run-time limitations, such as overheating, etc. A processor may obtainthe measured characteristics of the instrument for identifying aninstrument operating condition. In yet other embodiments, othermeasuring apparatuses are contemplated for measuring one or morecharacteristics of the instrument to facilitate the functionality of thedisclosed monitoring system. Accordingly, the description below shouldbe understood as exemplifying particular embodiments and implementationsof the invention, and not by way of limitation.

Reference will be now be made to the accompanying drawings, which assistin illustrating the various pertinent features of the various novelaspects of the present disclosure. The following description ispresented for purposes of illustration and description. Furthermore, thedescription is not intended to limit the inventive aspects to the formsdisclosed herein. Consequently, variations and modificationscommensurate with the following teachings, and skill and knowledge ofthe relevant art, are within the scope of the present inventive aspects.

In this regard, FIG. 1 presents a schematic representation an embodimentof a system 100 for monitoring an instrument that may include a workingtool 102 with a machine readable indicium 104. In this regard, themachine readable indicium 104 may be indicative of a working toolattribute corresponding to the working tool 102. For example, themachine readable indicium 104 may be indicative of one or more workingtool attributes of the working tool 102. In some instances, a machinereadable indicium 104 may convey a first attribute such as an identifierwhich may be used to identify or retrieve additional attributes.

According to another embodiment, the system 100 may include a pluralityof working tools 102 each with a respective machine readable indicium104. In turn, the respective machine readable indicium 104 may beindicative of or associated with a working tool attribute correspondingto the respective working tool 102 with which the respective machinereadable indicium 104 is associated. Accordingly, based in part on themachine readable indicium 104 facilitating the identification of aworking tool attribute, the various characteristics or properties of theworking tool may be communicated to an instrument or other associatedhardware to, for example, identify the working tool 102 and facilitatethe provision of an output responsive to a working tool attributereceived in relation to the machine readable indicium 104.

The system 100 for monitoring an instrument may also include aninstrument 106 with a machine readable indicia reader 108. In thisregard, the machine readable indicia reader 108 may receive anidentifier associated with working tool 102 via machine readableindicium 104. For example, working tool 102 may be received by theinstrument 106 such that the machine readable indicia reader 108receives an identifier associated with the working tool via theoperative association of the machine readable indicia reader 108 withthe machine readable indicium 104.

The machine readable indicium 104 may be disposed in proximal relationto the machine readable indicia reader 108 such that machine readableindicia reader 108 receives the identifier of the working tool viasignal 110. In this regard, signal 110 may be an electromagnetic signalgenerated at the machine readable indicium 104 in part by an inducedmagnetic field at the machine readable indicia reader 108 (as may be thecase for a passive RFID tag transferring electronically storedinformation to an RFID reader that produces a magnetic field). In othercases, signal 110 may include an optical signal for registration by themachine readable indicia reader 108.

Accordingly, based on the received identifier of the working tool, theinstrument 106 may identify a particular received working tool 102 alongwith the characteristics or properties related thereto. That is, thesystem 100 may include a plurality of working tools 102, with eachworking tool 102 including a respective machine readable indicium 104indicative of one or more working tool attributes associated with therespective working tool 102 at which the machine readable indicium isdisposed. The instrument 106 may be associable with any of the pluralityof working tools 102. In this regard, the instrument 106 may identify orotherwise register the particular working tool attributes associatedwith the respective engaged working tool 102 upon receipt of the workingtool 102 at the instrument 106. The identification of the particularworking tool attributes of the working tool 102 at the instrument 106may be processed at the instrument 106 and/or transmitted from theinstrument 106 to facilitate the provision of an output responsive tothe received identifier and/or identification of the instrumentoperating condition.

The system 100 for monitoring an instrument may also include acontroller 112 in operative communication with the instrument 106 viaelectronic signal 114. In this regard, the controller 112 may provide anoutput responsive to the received identifier. For example, theinstrument 106 may include an antenna and/or other output device fortransmission of electronic signal 114 to controller 112 such thatcontroller 112 may provide an output based at least in part on theinformation received via the electronic signal 114. As such, theelectronic signal 114 may carry or otherwise convey informationassociated with the working tool attribute and/or other characteristics,parameters, or conditions associated with the instrument 106 such thatthe controller 112 may provide an appropriate corresponding output. Theoutput may be communicated, for example, via a user portal, localdisplay, and/or other output element to facilitate monitoring theinstrument 106 and corresponding working tool 102. Preferably, suchcommunications of the electronic signal 114 are wireless. In thisregard, the instrument 106 and controller 112 may each include an RFtransceiver for conducting wireless communications in accordance with apublic or proprietary protocol such as a WAN, a LAN, and/or theinternet. The electronic signal 114 may also be communicated between theinstrument 106 and the controller 112 via a wireline connection. In someembodiments, a controller may be at least partially disposed within ahousing of an instrument and the electronic signal 114 may accordinglybe contained within the instrument.

In this regard, the controller 112 may facilitate monitoring theinstrument 106 by providing an output responsive to an identifiedinstrument operating condition, discussed in greater detail below. Thatis, the controller 112 may provide any appropriate output to prompt, forexample, corrective or other responsive actions by a user of the system100. For example, the controller 112 may provide an output responsive toa received working tool attribute that indicates an inventory levelcorresponding to a plurality of working tools 102, which may prompt auser to take a corrective action in relation to the indicated inventorylevel such as ordering additional units. As another non-limitingexample, the controller 112 may provide an output responsive to areceived or determined instrument operating condition that indicates oneor more characteristics corresponding to the environment in which thereceived working tool 102 advances during use.

In certain other embodiments, the controller 112 may be in operativecommunication with a remote server (not pictured) to facilitate analysisof the information received via electronic signal 114 in relation to oneor more correlation factors determined at the remote server. Forexample, the correlation factors may be determined at the remote serverbased on communications received from a plurality of controllers.Notably, each of the plurality of controllers may be in operativecommunication with a respective instrument (or a plurality ofinstruments) and configured to collect data in relation to one or moreparameters of the respective instrument or environment related thereto.In turn, this collected data may be transmitted to the remote server fordetermination of a correlation factor for application in subsequentutilizations of the instrument 106. In this regard, the controller 112may provide an output responsive to a received identifier and/oridentified instrument operating condition with respect to an instrumentcorrelation factor determined at the remote server. The correlationfactor may represent a threshold factor with which a measured value ofthe instrument 106 is compared to facilitate the identification of theinstrument operating condition, etc. Turning next to FIG. 2 , a detailedfunctional block diagram of system 100 is depicted in which various dataattributes such as working tool attributes, instrument operatingconditions, sensor values, and the like may be transmitted between theinstrument 106 and the controller 112 to facilitate monitoring theinstrument 106 and the working tool 102 received thereby. Broadly, thesystem 100 and the various components therein may include anyappropriate hardware (e.g., computing devices, data centers, switches,antennas, etc.), software (e.g., logic, computer readable instructions,applications system programs, engines, etc.), network components (e.g.,communication path interfaces, routers, etc.), and the like (notnecessarily shown in the interest of clarity) for use in facilitatingany appropriate operations of the network.

According to one embodiment, controller 112 and instrument 106 areconfigured for operative communication via electronic signal 114.Electronic signal 114 may be wired, wireless, or may be integrated intoan instrument. Electronic signal 114 may be transmitted over one or moreoptional data networks 116 in order to support the disclosed monitoringof instrument 106. In this regard, the controller 112 may be providedlocally to generate a response to facilitate real-time correctiveactions, such as when indicating an environmental condition throughwhich a received working tool 102 is advanced during use or may beprovided remotely to generate a response to facilitate systemremediation, such as when indicating an inventory level of a pluralityof working tools 102 that are associable with the instrument 106, etc.In some instances, an access terminal 118 may be provided forbi-direction communication with the instrument 106 and the controller112 via the one or more data networks 116. The access terminal 118,discussed in greater detail below, may facilitate providing the outputresponsive to the received identifier and/or the instrument operatingcondition by presenting the provided output of the controller as avisual or interactive display, etc.

The instrument 106 may generally employ various components to receive anidentifier of a working tool and facilitate the provisioning of anoutput responsive to the received identifier. The instrument 106 mayalso include various components to identify an instrument operatingcondition and facilitate the provisioning of an output related thereto.In this regard, the instrument 106 may include machine readable indiciareader 108 operatively connected to and controlled by processing engine120. Processing engine 120 may be integrally included with instrument106 to execute various modules or engines of the instrument 106,including facilitating the operation of various associated sensors orother data collection and analysis devices.

The instrument 106 may include one or more modules designed to collectand/or process information to facilitate the provision of a responsiveoutput at the instrument 106, controller 112, or other connected outputdevice. As such, in the illustrated embodiment, the instrument 106 mayinclude a first sensor 122 and a second sensor 124 configured to measureone or more parameters of interest. In this regard, the first and secondsensors 122, 124 may be embodied as a measuring apparatus foridentifying one or more characteristics of the instrument 106. Forexample, the first or second sensor 122, 124 may correspond to a sensorfor use in a displacement measuring apparatus. In other embodiments, thefirst or second sensor 122, 124 may correspond to a sensor for measuringthe rotational characteristics of the received working tool 102, asensor for measuring the power characteristics of the instrument 106such as voltage and current fluctuations, power efficiency, etc. or anyother sensor for measuring a parameter of interest such as a forcesensor configured to monitor an amount of force exerted by a user toadvance an instrument. In this regard, an output from the first andsecond sensors 122, 124 may be provided to the processing engine 120 asan electronic signal for manipulation, processing, and/or transmittingaccording to the embodiments described below.

For example, the instrument 106 may also include data collection module126 operatively associated with the processing engine 120 and first andsecond sensors 122, 124 for identifying an instrument operatingcondition. In this regard, data collection module 126 may obtain datacollected at first and second sensors 122, 124 via processing engine 120to identify the instrument operating condition.

Various parameter values or combinations of parameter values may beutilized to identify the instrument operating condition—the precisevalue, however, may vary depending on various factors, including theparticular received working tool 102, the environment of the instrument106, and/or the instant operation or application, as may be specified orpreprogrammed by a user of the system 100. In one embodiment, in whichfirst sensor 122 includes a sensor for use in a displacement measuringapparatus, information associated with the force applied at the workingtool 102, information associated with the displacement of working tool102 (i.e., relative to an axis along which the working tool 102 isadvanced during use), and/or derivatives thereof may be utilized toidentify an instrument operating condition indicative of, for example, adensity of a material through which the working tool is advanced duringuse. In some instances, it may be desirable to process the identifiedinstrument threshold values or algorithms such that the instrument 106may provide an output that prompts a user to take one or more correctiveactions.

In relation to the above instrument operating condition indicative ofdensity, for example, it may be desirable to generate an alarm viaactuation of alarm module 130 (discussed in greater detail below) if theinstrument 106 attempts to advance a working tool 102 through anenvironment consisting of a density that exceeds a predetermined value,such as 5.00 or 5.50 g/cm². Alternatively, an alarm may be generatedbased on an abrupt increase or decrease in density such as more than 0.5g/cm² in one second or several seconds, for example. As anotheralternative, an alarm may be generated based on a combination of theseparameters such as density is rising at more than 0.5 g/cm² per secondand density exceeds 5.00 g/cm². It will be appreciated that suchthresholds or related algorithms may be based on the particularapplication of the instrument 106, and may incorporate the variousexpertise, experience, and evolving standards of a user of system 100.It will be appreciated that additional or alternative instrumentoperating conditions along with associated threshold values andcorresponding alarms may be determined at least partially analogous tothe manner described above, including instrument operating conditionsdetermined based on information received from other describedembodiments of first and second sensors 122, 124 and information inrelation to a received identifier.

To facilitate the foregoing generation of an alarm or other responsiveoutput, various parameter values may be utilized, for example, toquantify a threshold condition, range, etc. In this regard, theforegoing parameter values may be stored in a local database in theinstrument 106 such as storage 128. The storage 128 may includeinformation for use by the processing engine 120 and data collectionmodule 126 in executing the noted functionality. For example, thestorage 128 may include standardized operating parameters or otherattributes in relation to the instrument 106 and/or the received workingtool 102, threshold values or algorithms to facilitate determination ofalarm conditions, environmental conditions, and any other appropriatedata attributes for determining when an alarm should be triggered. Thisinformation may be stored prior to use of the instrument 106 or may beupdated via wireless or other methods via electronic signal 114, forexample, transmitted over the one or more data networks 116.

The processing engine 120 may implement a variety of differentalgorithms for obtaining values such as those measured by first orsecond sensor 122, 124, identifying an instrument operating condition,and/or determining whether an alarm should be triggered. Such algorithmsmay involve simple comparison of values, such as comparing a currentdisplacement value to a displacement value threshold. Alternatively,such algorithms may involve accessing one or more parameters from aremote server in order to facilitate the analysis of the obtainedmeasured values, as discussed in greater detail below. For example, theprocessing engine 120 may determine a threshold displacement valueappropriate for the instant operating conditions of the instrument 106in part by reference to a remote central processor that provides acorrelation factor based in part on aggregated information received froma plurality of instruments.

The alarm module 130 of instrument 106 may include an audio alarm,vibrating devices, wireless alerts, updated or other notifications viaphone applications, a visual alarm, or any other system for alerting auser to the identified instrument operating condition. For example, thealarm module 130 may include LEDs, audio tone generators, or the like.In the case of the instrument 106 embodied as a handheld tool, visualalarms such as illuminating an LED when a threshold condition is reachedmay be particularly useful in notifying a user of an instrumentoperating condition. Accordingly, the alarm module 130, through one ofthe foregoing described techniques, may alert a user to theidentification of an instrument operating condition or other determinedoutput. In this regard, as the user is alerted to the instrumentoperating condition, the user may take appropriate corrective actions orbe prompted by a third party to do so. For example, an alarm indicativeof a target displacement of the working tool 102 may prompt the user tostop advancement of the working tool 102.

The instrument 106 may also include communication module 132 tofacilitate the bidirectional communication between the instrument 106and controller 112. For example, the communication module 132 mayinclude an RF transceiver for conducting wireless communications. Inother instances, the communication module 132 may include a port orother hardwired connection to facilitate wireline communications. Ineither event, the communication module 132 is configured to transmit andreceive electronic signal 114 via the one or more data networks 116.

In some embodiments, the instrument 106 may also include a battery 134operable for providing power to the instrument 106 and each of theassociated processors, modules, and sensors included therein. In someinstances, the battery 134 may be recharged by a recharge module 136,which may include a re-charge induction coil and/or a port forconnecting to an AC power source or other recharging power source.

As described above, the instrument 106 may transmit one or moreelectronic signals to the controller 112 to facilitate the describedmonitoring of instrument 106 and received working tool 102. Accordingly,the controller 112 may include various components and modules to receiveand transmit data with the instrument 106 to facilitate the foregoingfunctionality. In the illustrated embodiment, as depicted in FIG. 2 ,the controller 112 may include a memory 138 (e.g., RAM, other volatilemodules, etc.) that contains one or more modules or engines that processdata received from the one or more data networks 116; a processingengine 140 that executes the modules or engines from the memory 138;storage 142 (e.g., one or more magnetic disks, solid-state drives, orother non-volatile memory modules) for storing received and generateddata; communications module 143; and a number of other components 144(e.g., input devices such as a keyboard and a mouse, a transceiver inoperative communication with the communications module 143 fortransmitting and receiving electronic signals to and from the instrument106, other devices such as a display and speakers, and the like), all ofwhich may be appropriately interconnected by one or more system buses146.

The one or more engines of the controller 112 may generally facilitateprocessing of data received via the one or more data networks 116 formonitoring of the instrument 106 and storing the resultant data in oneor more databases of storage 142. Each of the engines may be in the formof one or more sets of computer readable instructions for execution bythe processing engine 140, and may be manipulated by a user in anyappropriate manner to analyze and configure the measured, received, orgenerated data as disclosed herein. Each of the engines may also bemanipulated to configure the data stored in the one or more databases ofstorage 142 for transmission via the one or more data networks 116. Inthis regard, the combination of processing engine 140, memory 138,and/or storage 142, and the various engine/modules disclosed herein inone embodiment create a new machine that becomes a special purposecomputer once it is programmed to perform particular functions of theutilities disclosed herein. While various engines have been depicted inFIG. 2 as being separate and distinct engines, it is understood that thefunctionalities or instructions of two or more engines may actually beintegrated as part of the same computer-readable instruction set, andthat the various engines have been depicted in the manner shown in FIG.2 merely to highlight various functionalities of the system.

In one arrangement, the controller 112 may include a data collectionmodule 148 that receives incoming data over the one or more datanetworks 116 for executing one or more processing functions and storingthe received and/or processed data in storage 142 in any appropriatemanner. In this regard, storage 142 may include a thresholds/conditionsdatabase 150 for storing various parameter values for use in identifyingthe instrument operating condition, etc.; a past performance database152 for storing historical data and metrics associated with previouslyidentified instrument operating conditions, including past and currentinventory levels of a plurality of working tools 102 associable with theinstrument 106, etc.; and a user database 154 for storing dataassociated with various users of the instrument 106, etc. In thisregard, the controller 112 may also include a database builder 156 thatis configured to manipulate the received and/or processed data tocreate, structure, or otherwise format the various databases of storage142. In this regard, the database builder 156 may be configured tostructure the various data attributes stored in storage 142 tofacilitate the monitoring of instrument 106 and identification of aninstrument operating condition. In this regard, the database builder maystructure received data attributes of the thresholds/conditions database150 in corresponding relation to various anticipated measured dataattributes to facilitate identification of a corresponding instrumentoperating condition, etc.

As discussed above, controller 112 may include data collection module148. According to one embodiment, data collection module 148 may performsubstantially all of the functions described with respect to datacollection module 126 of instrument 106, including the generation of analarm output in relation to an identified instrument operatingcondition. In this regard, the data collection module 148 may beconfigured for identifying an instrument operating condition based on,for example, a measured data value obtained via the first or secondsensors 122, 124. Additionally, the data collection module 148 may beconfigured for receiving an identifier of a working tool. In thisregard, the data collection module 148 may receive data measured orgenerated at the instrument 106 for identifying the instrument operatingcondition and/or a working tool attribute.

The data collection module 148 may facilitate the identification of anyinstrument operating condition of interest as may be specified orotherwise preprogrammed, for example, by a user in relation to aparticular use case, etc. In some instances, the identification of aninstrument operating condition may involve accessing one or moredatabases of storage 142 for comparison or analysis with one or moremeasured or generated data attributes of the instrument 106. Accordingto one embodiment, the instrument operating condition may include acondition indicative of a condition-dependent status of the instrument106. For example, the condition-dependent status may be indicative of aphysical condition of the instrument 106. In this regard, for the sakeof non-limiting example, the condition-dependent status may correspondto the physical condition of a drive system of the instrument 106. Thedata collection module may therefore be configured to identify suchinstrument operating condition, for example, by comparing a data valuemeasured at first sensor 122 (e.g., the operating temperature of thedrive system) with an accessed data value of the thresholds/conditionsdatabase 150 (e.g., corresponding to a normal operating temperaturerange for the drive system). Accordingly, the condition-dependent statusmay be at least partially based on this comparison of values (e.g., thecondition-dependent status may indicate that the noted drive system“Needs Servicing” or any other appropriate indicators in relation to theforegoing comparison).

In yet another embodiment, the instrument operating condition may beindicative of an inventory-dependent status. As noted, in someinstances, the working tool 102 may be one of a plurality of workingtools associated with the system 100, each receivable by the instrument106. In this regard, it may be desirable for a user of the system 100 toreceive an indication in relation to the quantities of working tools 102of the plurality of working tools remaining within the system 100 forassociable use with the instrument 106. To facilitate the foregoing, thedata collection module 148 may receive data over the one or more datanetworks 116 corresponding to identifiers received at the instrument106. For example, the identifier may be a working tool serial numberthat uniquely identifies the respective working tool 102 received by theinstrument 106. The unique identification of the working tool may, inturn, be compared against a predetermined inventory level of workingtools in order to account for the use of the instant received workingtool 102.

In some embodiments, a machine readable indicium on a working tool maybe read by a machine readable indicia reader 108 of an instrument 106which generates or transmits an indication of an identifier associatedwith the working tool and more specifically, with the machine readableindicium. In this regard, the identifier may be a serial number or anyother unique identification mechanism associated with the working toolto distinguish the particular working tool from other, perhaps similar,working tools. In this sense, the word “unique” is intended to indicateonly that the identifier is unique within a given set of working toolsand need not be entirely unique in a global sense.

Upon engagement of a working tool with an instrument 106, the identifier(e.g., serial number) of the working tool may be read and stored in adatabase. Such a database may be locally disposed in the instrument 106or in a controller 112 associated with the instrument 106, remotelydisposed in a database in operative communication with a plurality ofinstruments, or in a global database in communication with allinstruments capable of engaging the working tools described herein, forexample. The identifier of a given engaged working tool may bereferenced against such a database prior to operation of the instrument106. In this regard, if the identifier is found in a database whichcontains identifiers of previously used working tools, certainconditions may be placed upon operation of the instrument 106. Forexample, if a working tool is considered to be a one-time use ordisposable device, then the instrument 106 may be prevented fromoperation based upon a determination that an engaged working tool hasbeen previously used, locally or remotely (such as with anotherinstrument at another facility). In the case that a working tool isdesignated or approved for only a single use, such as in athresholds/conditions database, any subsequent attempts to utilize theworking tool after an initial registration with an instrument may bedenied by a controller. As another example, certain working tools may berestricted to a single patient or may be associated with a maximumoperational life. In the former regard, each time a working tool isengaged with an instrument 106 (or more or less frequently), a databasemay be referenced to determine if the given working tool has been usedon another patient. If so, the instrument 106 may be prevented fromengaging the drive motor based on a control signal, or lack thereof,received from the controller 112. In the latter regard, each time aninstrument is operated, the time elapsed during use may be recorded in adatabase which maintains total use times of each working tool. A rule(stored for example, in thresholds/conditions database 150) may be usedto establish a maximum operational life such that at any time the totaluse time of a particular working tool reaches or exceeds the maximumoperational life, all instruments associated with that working tool maybe prevented from further operation if the working tool is engagedtherewith.

A controller 112 may be operable to send a request to a remote serverincluding a working tool identifier. The remote server may utilize theidentifier to process rules, lookup data associated with the identifier,and/or transmit an output back to the controller 112. In response toreceipt of the output, the controller 112 may be operable to restrict orpermit operation of the instrument 106. Alternatively, a remote servermay not be utilized. Rather, the controller 112 may itself beoperational to lookup data associated with a working tool identifier, toprocess rules which determine operation limitations, and implementpolicies in accordance with the rules to permit or restrict operation ofthe instrument 106. For example, the controller 112 may be in operativecommunication with a drive motor of the instrument 106. In the absenceof the receipt of a working tool identifier at the controller 112 (whichmay indicate a counterfeit, unapproved, improperly refurbished, orotherwise incompatible working tool), or in the event that an identifieris associated with an unacceptable condition (e.g., the working tool hasbeen previously used and is therefore incompliant with standards ofcare), the controller 112 may prevent engagement of the drive motor.Similarly, a rule may indicate that the identifier is associated with alimited operating speed. In response, the controller 112 may limit thespeed of the drive motor of the instrument 106.

In still other embodiments, a database of standard operations, such assurgical procedures or medical operations may be maintained locally orremotely. A user may select a standard operation at an access terminal118 in communication with a given instrument 106 or set of instruments.The standard operation may be associated with a set of rules or otherspecifications regarding working tools that may be used in accordancewith standard operating procedures. For example, a particular type ofoperation (e.g., ACL reconstruction) may require or otherwise beassociated with working tools having a particular material composition,a particular manufacturer, a given range of diameters and/or lengths,etc. for compliance with regulations or standards of care. In thisregard, an instrument may be associated with an operation, for example,by manual data entry into the access terminal. Upon engagement of aworking tool with the instrument, the database may be referenced todetermine if the attributes of the working tool engaged with theinstrument are compatible with the instrument and/or meet thespecifications of the operation. If the attributes comply with therequirements of the operation, a drive motor of the instrument may beallowed to operate. If one or more attributes of the working tool, asdetermined based upon the identifier, do not comply with therequirements of the operation, the drive motor may be prevented fromengaging and/or an alert to the user may be triggered.

In some instances, working tools or other medical devices used duringsurgery may become misplaced and in a few cases, may be unintentionallydeposited within a surgical site of a patient. In order to ensure allworking tools are accounted for upon completion of a procedure,inventory may be taken. To facilitate such inventory accounting, a listof working tools used during a procedure may be maintained in a local orremote database. Upon completion of the procedure, the list may be usedto manually or automatically take inventory of used working tools. Forexample, each working tool engaged with an instrument used during theprocedure may have a unique identifier which is maintained in a list ofused working tools. The list may be presented to a user on a display ofan access terminal for manual verification that all used working toolsare accounted for. Additionally or alternatively, a machine readableindicia reader (either disposed in an instrument or independently) maybe utilized to scan or otherwise read the machine readable indicium ofeach working tool collected upon completion of the procedure. If anidentifier is present on the list of used working tools (therebyindicating the associated working tool was used during the procedure)but the working tool associated with the identifier is not scanned uponcompletion of the procedure, an alert may be triggered to the user viaan instrument, a controllers, access terminal, etc. In certain otherembodiments, the instrument operating condition may be indicative of anenvironment through which the working tool 102 is advanced during use,including one or more characteristics of the environment such asenvironment density. In this regard, the data collection module 148 mayprocess one or more data attributes measured by, for example, the firstor second sensors 122, 124 in order to obtain information in relation tothe environment through which the working tool 102 is advanced. Forexample, according to one embodiment, the first sensor 122 may beconfigured to measure the displacement of the working tool 102 relativeto an axis along which the working tool 102 is advanced during use.Additionally, the second sensor 124 may be configured to measure theforce presently applied at the working tool 102. In this regard, theinstrument operating condition, as identified by the data collectionmodule 148, may be at least partially based on the measured displacementof the working tool 102 and the measured forced applied at the workingtool 102.

As such, the instrument operating condition may be indicative of adensity of the environment through which a working tool of theinstrument is advanced during use. In this regard, the instrumentoperating condition may dynamically change with the operation of theinstrument 106. For example, the working tool 102 may be advancedthrough an environment with a variable density or through an environmentwith several discrete changes in density. As such, the instrumentoperating condition may be compared in real time to one or more datavalues which may be stored, for example, in thresholds/conditionsdatabase 150 in order to facilitate the provision of an alarm output inrelation to the identified instrument operating condition. For example,as described above in relation to alarm 130, an alarm output responsiveto the comparison of the identified instrument operating condition withthe one or more parameter values may alert a user to a condition ofinterest and/or prompt a user to take various corrective actions.

To illustrate the foregoing, consider that the instrument 106 may beembodied as a surgical instrument disposed for measuring thedisplacement of a received working tool 102 relative to an exteriorsurface of a surgical site during a surgical operation. In this regard,the working tool 102 may be embodied as a surgical drill bit.Accordingly, the instrument operating condition may be configured to beindicative of a bone density. As will be described in greater detailbelow, the particular value of the bone density through which theworking tool 102 is advanced may be indicative of various stages of asurgical procedure involving various stratums of tissue, as depicted ingreater detail in FIGS. 13A-13C). In this regard, the instrumentoperating condition may support aspects of the surgical operation byalerting the user to particular changes in bone density that may promptvarious corrective actions.

In some instances, the particular value of the instrument operatingcondition may be compared for analysis with one or more threshold valuesin order to provide an alarm output corresponding to a condition ofinterest. That is, one or more threshold values or conditions may beassociated with a change in bone density that prompts the correctiveaction by the user. Notably, however, the particular threshold value ofbone density may be different for each subject of a medical operationbased on demographics, medical conditions and history, or otherindividualized characteristics. Accordingly, the data collection module148 may be operable to associate the instrument operating condition withone or more health history characteristics of the subject. That is, thedata collection module 148 may access one or more particular healthhistory characteristics of the particular subject undergoing thesurgical operation to determine a threshold value for the instrumentoperating condition in order to facilitate the provision of an alarm orother appropriate output. In this regard, the data collection module 148may compare the instrument operating condition to a particular subject'shealth history characteristic, which may include a subject's age,weight, sex, nationality, geographic location, medication history,disease history, and/or any other appropriate characteristic that mayfacilitate the identification of an appropriate threshold value forcomparison with the instrument operating condition indicative of bonedensity. In some instances, this may include execution of one or morealgorithms as described above in relation to alarm module 130 ofinstrument 106.

In certain other embodiments, the controller 112 may also includeanalytics engine 158 in operative communication with the data collectionmodule 148 and configured to analyze the identified instrument operatingcondition and/or the received identifier as identified or received ateither the controller 112 or the instrument 106. For example, theanalytics engine 158 may generate one or more metrics displayable at auser portal, in order to facilitate the disclosed monitoring ofinstrument 106. In this regard, the analytics engine 158 may provideinformation for use in taking corrective actions in response to theidentified instrument operating condition and/or received identifier.Furthermore, the controller 112 may also include a portal 160 such as anInternet or web-based platform to facilitate transmitting informationassociated with identifying the instrument operating condition and/orthe working tool attribute to access terminal 118. In some embodiments,the controller 112 may receive data from the access terminal 118 via theone or more data networks 116.

In another embodiment, the controller 112 is one of a plurality ofcontrollers 112 that collectively communicate to form a distributednetwork. In this regard, each of the plurality of controllers 112 may bein operative communication with a central processing server (notpictured) remote from the plurality of controllers 112. Each of theplurality of controllers 112 may also be in operative communication witha respective instrument 106 or a plurality of instruments and able toidentify an instrument operating condition and/or received identifierassociated with the respective instrument. As such, information fromeach of the controllers 112 may be sent to the central processor toanalyze one or more parameters. For example, each of the controllers 112may transmit information to the central processor in relation to aparticular identified instrument operating condition of interest, suchas bone density for a respective subject undergoing a surgical operationwith the respective instrument, etc.

By way of continued example, the controller 112 may transmit themeasured bone density with regards to identified subjects thatcorrespond to the specified medical history of the patient. In thisregard, the central processor may aggregate such information in order todetermine an aggregate threshold value for identifying an instrumentoperating condition value that will facilitate the provision of an alarmoutput for a subject with similar medical history characteristics. Forexample, this aggregated value may result in the determination of one ormore correlation factors that may be transmitted to one or morecontrollers. In this regard, upon the subsequent operation of theinstrument 106, the controller 112 may be configured to generate aresponse based on an identified instrument operating condition asanalyzed with respect to the received correlation factor. As such, thecontroller 112 may leverage the information received at the centralprocessor in order to more accurately identify the instant instrumentoperating condition. This may be accomplished by executing a predictivealgorithm based on the correlation factor to predict an instrumentoperating condition in a particular use case of the instrument 106, forexample.

The embodiments of a controller 112 and instrument 106 are provided forexemplary illustration only. Certain components illustrated in FIG. 2 asbeing part of instrument 106 may optionally be disposed in controller112. For example, processing engine 120 may be the same as processingengine 140. In this regard, all operation of the instrument may beprocessed by processing engine 140 of the controller 112 which may ormay not be disposed within instrument 106. Furthermore, data collectionmodule 126 may be data collection module 148, communications module 132may be communications module 143, and storage 128 may be storage 142.Furthermore, alarm 130 may be disposed within controller 112.

Turning next to FIG. 3 , a more detailed functional block diagram of theaccess terminal 118 for use in receiving and transmitting informationwith the controller 112 is depicted. The access terminal 118 maygenerally employ various components to receive and transmit information.In this regard, as shown, the access terminal 118 may include a display162 that presents information associated with the controller 112 to auser via a user interface 164; processing unit 166 configured to processreceived information; memory 168; and storage 170 for storing receivedand/or processed information. Additionally, the access terminal 118 maybe configured to receive input 172 in response to information presentedon display 162 and transmit output 174 which may be indicative of arequest for information from the controller 112, etc. . . . . In thisregard, the controller 112 may transmit information between the portal160 and the access terminal 118 via the one or more data networks 116.For example, this may occur by any appropriate browser (not shown)running on the memory 168 of the access terminal 118 that mayappropriately access the portal 160 via the one or more data networks116.

Reference will now be made to a number of representative screen shots ofthe portal 160 that may be presented on, for example, display 162 of theaccess terminal 118 and that may be manipulated by a user to configurethe monitoring of the instrument 106 as described in detail below. Itshould be understood that the various functionalities disclosed hereinare not limited to use with such specific screenshots as presented.Rather, the screen shots are merely provided to facilitate the reader'sunderstanding of the various programs, modules, and otherfunctionalities disclose herein.

Starting now with FIG. 4 , a screenshot 400 is depicted in which aworking tool report 402 is displayed. Broadly, the working tool report402 may include various configurations of information for use inidentifying an instrument operating condition, such as aninventory-dependent status. As noted, the respective working tool may beone of a plurality of working tools receivable by the instrument 106. Inthis regard, it may be desirable to present information in relation tothe usage of the plurality of working tools.

According to one embodiment, the working tool report 402 may includeinventory level monitoring graph 404 for use in displaying the foregoinginformation in a graphical format. In this regard, the inventory levelmonitoring graph 404 may include a time axis 406 (shown extendinggenerally along an x-axis in the illustrative example) and an inventorylevel axis 408 (shown extending generally along a y-axis in theillustrative example).

To illustrate the foregoing, the inventory level monitoring graph 404may include one or more graphical lines. For example, the inventorylevel monitoring graph 404 may include aggregate working tool inventoryline 410 indicative of an aggregate inventory level of the plurality ofworking tools which may indicate a total count of the plurality ofworking tools available for association with the instrument, as filteredby various user criteria as a function of time. According to oneembodiment, each received identifier of a respective working tool at theinstrument may facilitate the identification of the inventory-dependentstatus of the instrument operating condition. For example, the datacollection module may decrease the inventory-dependent status for eachreceived identifier which is indicative of the working tool beingutilized such that it cannot subsequently be associated with theinstrument 106 after the instant use. In this regard, the aggregateworking tool inventory line 410 may generally decrease over a period oftime with each subsequent use of a respective received working tool, asrepresented with respect to the time axis 406. Alternatively, theaggregate working tool inventory line 410 may periodically increase. Forexample, the identified inventory-dependent status may be updated basedon a restocking or resupply of the plurality of working tools.

The inventory level monitoring graph 404 may facilitate the dynamic orsubstantially real-time monitoring of the inventory-dependent status viathe aggregate working tool inventory line 410. For example, theaggregate working tool inventory line 410 may include current inventorylevel 412. In this regard, the inventory level monitoring graph 404 mayprovide an indication to a user of the system indicative of theinventory level of working tools associable with the instrument 106. Insome instances, the current inventory level 412 may be accompanied by afloating box 414 operable to provide additional information in relationto the current inventory level 412. In this regard, according to oneembodiment, the floating box 414 may include current inventory statusindicator 416.

More generally, working tool report 402 may include other indicators orvisual modules to facilitate the dynamic or substantially real-timemonitoring of the inventory-dependent status. For example, the workingtool report 402 may include “zero” inventory indicator 418 configured toprovide an indication in relation to the estimated time until thecurrent inventory level 412 will be equal to zero units (assuming thatadditional working tools 102 are not subsequently added to the pluralityof working tools 102). In this regard, the zero inventory indicator 418may be based on a variety of measured and determined factors includingthe rate at which the inventory of the plurality of working tools 102 isdepleted. In some instances, the rate at which the plurality of workingtools 102 is depleted may be represented at inventory level monitoringgraph 404 by anticipated inventory level line 419. In this regard, theanticipated inventory level line 419 may be configured to project theaggregate inventory level based on an analysis of historical inventorylevels which may include reference to data stored at past performancedatabase 152, etc. Accordingly, the foregoing functionalities may prompta user to take corrective actions to facilitate maintenance of anappropriate inventory level of the plurality of working tools 102associable with the instrument 106.

Such corrective actions may be facilitated by the functionality of theworking tool report 402. For example, the working tool report 402 mayinclude reordering button 420 to facilitate the replenishment of theinventory level of the plurality of working tools 102. In this regard,the reordering button may be manipulated by a user to increase theinventory level. In this regard, reordering button 420 may includeinitiate bar 422 configured to accept a response from a user that causesinitiation of a preprogrammed ordering protocol. As such, the inventorylevel may be manually increased by the manipulation of the initiate bar422. In this regard, in some instances, manipulation of the initiate bar422 may trigger a variety of events, such as, placing an order for theadditional inventory, assigning the inventory to a physical location,and/or other appropriate logistical functions.

Furthermore, the reordering button 420 may also include predictive bar424 configured to accept a response from a user that causes initiationof a preprogrammed ordering protocol to automatically increase theinventory level of the working tools 102. For example, the datacollection module 148 may monitor one or more parameters displayable atthe working tool report 402 in order to determine an appropriate time atwhich to initiate a preprogrammed ordering protocol to increase theinventory level of the plurality of working tools 102.

Working tool report 402 may also facilitate displaying information inrelation to various working tools 102 of interest. In this regard, theworking tool report 402 may include detail inventory display 426configured to display various details associated with a particular, orsubset of, working tools 102 of the plurality of working tools 102. Inthe illustrated embodiment, the detail inventory display 426 may includea serial no. column 428, a size column 430, a material column 432, acase no. column 434, and an inventory column 436. It will beappreciated, however, that in other embodiments, more or less columnsmay be included at the detail inventory display 426 as may beappropriate and/or of interest to a user in relation to thecharacteristics of a particular working tool 102.

Consider, for the sake of illustration, row 426 a of detail inventorydisplay 426, which displays various information attributes associatedwith a working tool 102 uniquely identified by serial number 17483,according to serial number column 428. In particular, row 426 a includesinformation pertaining to various characteristics of the working tool102 identified by serial number 17483. For example, the working toolidentified by serial number “17483” may be associated with a size of “⅜inch” and be associated with a material of “Titanium SS”. In some cases,the working tool 102 may be prospectively assigned to a use case (e.g.,a planned use of the working tool 102 for a particular case or scenario,such as a particular planned surgery, etc.). In this regard, the workingtool 102 identified by serial number 17483 may be associated withprospective use case number “10578”. In some instances, the data valuedepicted at the case no. column 434 may be manipulable by a user suchthat additional information may be presented in relation to therespective use case number. In other words, manipulation of the value ofthe case number value No. 10578 may present information to a user inrelation to an upcoming surgery during which the working tool 102identified by serial number 17483 may be scheduled for use, etc.

In some instances, the user may desire to obtain information pertainingto the inventory level of a particular subset of working tools 102. Inthis regard, the user may manipulate a “Report” link in row 426 a inorder to display information in relation to an inventory-dependentstatus corresponding to the plurality of working tools that share one ormore particular characteristics of the working tool 102 identified byserial number 17483. In this regard, the detail inventory display 426,may facilitate the provision of additional information in relation tothe inventory level of working tools with characteristics similar to thecharacteristics of the working tools 102 listed at the detail inventorydisplay 426.

Additionally, the information displayed at the inventory levelmonitoring graph 404 may be manually filtered according to thepreferences of a system user. In this regard, the working tool report402 may include a filter inventory results button 438 configured tofacilitate the presentation of information at inventory monitoring graph404 in relation to the desired preferences. In this regard, the filterinventory results button 438 may include a size field 440, a materialfield 442, a manufacture field 444, and a weight field 446. Accordingly,each of the foregoing fields may be operable to accept a response from auser in order to facilitate the presentation of information at theinventory level monitoring graph 404 relative to the accepted responses.It will be appreciated that in some instances more or fewer fields maybe configured to accept a user response according to the particularembodiment. Additionally, all fields associated with the filterinventory results button need not receive a response from a user inorder to facilitate the foregoing filtering functionality.

According to the illustrated embodiment, the filter inventory resultsbutton 438 may accept a response in relation to a working tool size of“⅜ in”, a working tool material of “Cobalt”, a working tool manufactureof “ABC Corp.”, and a working tool weight of “Light”. As such, based onthe foregoing received responses of the illustrated embodiment,manipulation of the filter inventory results button 438 may cause theinventory level monitoring graph 404 to display information associatedwith the inventory level of the subset of the plurality of working tools102 that correspond to a size of ⅜ inch, a material of Cobalt, amanufacture of ABC Corp. and a weight of Light. In turn, each of thevarious metrics and other analytics devices described above may beupdated to reflect the manipulation of the filter inventory resultsbutton 438.

Turning next to FIG. 5 , a screenshot 500 is depicted in whichinstrument monitoring report 502 is displayed which may facilitate thedynamic or near real-time monitoring of the instrument 106 and/or theenvironment through which a received working tool 102 is advanced duringuse, etc. Broadly, the instrument monitoring report 502 may includevarious configurations of information for use in displaying informationin relation to an identified instrument operating condition, forexample, such as the density of the material through which the workingtool 102 is advanced during use. As previously described, the identifiedinstrument operating condition may be at least partially based on dataobtained from first and second sensors 122, 124 of the instrument 106such as data indicative of a measured force applied at the working tool102, data indicative of a measured axial displacement of the workingtool 102, etc. In this regard, the instrument monitoring report 502 maybe configured to present information to a user in relation to suchmeasured data and metrics determined in relation thereto, which mayprompt a user to take corrective action based on the presentedinformation during use of the instrument 106, etc. For example,presenting information in relation to the density of the materialthrough which the working tool 102 is advanced during use may facilitatevarious corrective actions in relation to the use of the instrument 106.

According to one embodiment, the instrument monitoring report 502 mayinclude density graph 504 for use in displaying an instrument operatingcondition indicative of the density of the material through which theworking tool 102 is advanced during use. It will be appreciated,however, the density graph 504 is only one illustrative embodiment ofthe contemplated functionality of the instrument monitoring report 502.In other embodiments, the instrument monitoring report 502 may includeother graphs of various different identified instrument operatingconditions corresponding to a condition of the instrument analogous tothe functionality described herein. For example, a graph may bepresented in relation to power consumption, maintenance indicatorlevels, and the like. In this regard the density graph 504 may include atime axis 506 and an environment density axis 508.

To illustrate the foregoing, the density graph 504 may include one ormore graphical lines. For example, the density graph 504 may includeanticipated density line 510 indicative of an anticipated density of theenvironment through which the working tool 102 is to be advanced duringa particular use case. Additionally, the density graph 504 may includemeasured density line 512 indicative of a measured density of theenvironment through which the working tool 102 is advanced during use.The measured density line 512 may be based at least in part on measuredvalues obtained at the first and second sensors 122, 124, such as forcesmeasured at the working tool 102 and the displacement of the workingtool.

The information displayed at the density graph 504 may correspond to aparticular use case of the instrument 106. That is, the instrument 106may be used for particular defined task for which the instrumentoperating condition is identified and analyzed. In this regard, thedensity graph 504 may display the anticipated density line 510 and themeasured density line 512 in relation to the time or sequence of eventsof the particular use case. For example, at least the measured densityline 512 may be displayed in relation to a start time 514 of the usecase. In this regard, the start time 514 may correspond to theinitiation of the particular use case of the instrument 106. As such,the measured density line 512 may increase and decrease in relation tothe time axis 506 as initiated at the start time 514. The measureddensity line 512 may conclude at current measured density 516 indicativeof the currently measured density. In this regard, as the density graph504 may include information about the present operating condition and/orenvironment of the instrument 106, a user may be prompted to takecorrective actions by reference to the information contained therein.

In some instances, the current measured density 516 may be accompaniedby floating box 518 configured to provide additional information inrelation to the currently measured density 516. In this regard,according to one embodiment, the floating box 518 may include currentmeasured density indicator 520 to numerically indicate to a user thevalue of a currently measured density 516 presented at density graph504. More generally, the density graph 504 may facilitate the comparisonof a measured value with an anticipated or projected series of values.In some instances, this may be embodied as a visual comparison betweenvarious graphical lines depicted at the density graph 504. In yet otherinstances, the instrument monitoring report 502 may provide one or moremetrics to facilitate the foregoing comparison. For example, accordingto the illustrated embodiment of FIG. 5 , the floating box 518 mayinclude a deviation from projected value indicator 522 to numericallyindicate a percentage deviation of the measured density line 512 withthe anticipated density line 510. Accordingly, the floating box 518 mayprompt the user to take one or more corrective actions based on theinformation contained therein.

Additionally, the instrument monitoring report 502 may include summaryinformation button 524 configured to provide one or more data parametersor characteristics in relation to the particular use case correspondingto the information depicted at the density graph 504. In this regard,the summary information button 524 may include a case no. field 526, arisk profile field 528, a material field 530, and a criticality field532. Accordingly, each of the foregoing fields may be configured toindicate information in relation to the instrument operating conditionas depicted at density graph 504. It will be appreciated that in someinstances, more or fewer fields may be configured to indicateinformation in relation to the particular use case.

According to the illustrated embodiment, the summary information button524 may indicate that information depicted at density graph 504corresponds to the particular use case of “No. 10578”. By way ofnon-limiting example, this particular use case “No. 10578” maycorresponding to use of the instrument 106 in a surgical operation. Inthis regard, one or more parameters may be indicated in relation to thecharacteristics of this particular use case. For example, the use caseNo. 10578 may correspond to a “high” risk profile (as shown in riskprofile field 528), for drilling through a “bone” material (as shown inthe material field 530), during a procedure indicated as an “urgent”criticality (as shown in the criticality field 532). Notably, theinformation indicated at the foregoing fields may prompt the user, inconjunction with additional information displayed at instrumentmonitoring report 502, to take one or more corrective actions. Forexample, the indication at risk profile field 528 may prompt the user tooperate the instrument 106 in a manner consistent with a correspondinguse case.

Additionally, the instrument monitoring report 502 may be configured toprovide information in relation to the working tool 102 associated withthe particular use case for which the density graph 504 depicts theinstrument operating condition. In this regard, the instrumentmonitoring report may include working tool button 534 configured formanipulation by a user to cause information to be displayed in relationto the received working tool 102. The working tool button 534 mayinclude status tab 536 and inventory tab 538. The status tab 536 may bemanipulated by a user such that the instrument monitoring repot 502displays information in relation to the characteristics or parametervalues of the working tool 102 used in the instant use casecorresponding to that depicted at the density graph 504. For example,manipulation of the status tab 536 may cause information to be presentedin relation to a working tool size, a working tool material, a workingtool weight, a working tool manufacturer, a working tool serial number,and/or any other characteristics of interest associated with thereceived working tool 102. Relatedly, the inventory tab 538 may bemanipulated by a user to cause information associated with aninventory-dependent status corresponding to the subset of working tools102 that share at least some of the same attributes of the receivedworking tool 102 of the instant use case. For example, manipulation ofthe inventory tab 538 may cause working tool report 402 to displayinformation at the inventory level graph 404 that corresponds to thesubset of the plurality of working tools 102 that share the samecharacteristics of the received working tool 102 of the instant usecase. This may be desirable, for example, in order to indicate aquantity of the plurality of remaining working tools 102 that remainavailable for associable use for an analogous subsequent use case or maybe useful in cases where multiple working tools 102 are required tocomplete a single use case, etc.

To further facilitate the reader's understanding of the variousfunctionalities of the utilities disclosed herein, reference is now madeto flow diagram of FIG. 6 , which illustrates method 600 for use inmonitoring an instrument. While specific steps and orders of steps ofmethod 600 have been illustrated and will be discussed, other methods(including more, fewer, or different steps than those illustrates)consistent with the teaching presented herein are also envisioned andencompassed with the present disclosure.

In this regard, with reference to FIG. 6 , method 600 generally relatesto a method for monitoring an instrument, for example, when receiving aworking tool associated with one or more working tool attributes. Inthis regard, the method 600 may be initiated by engaging 602 a workingtool with an instrument. For example, a working tool may be engaged withthe instrument by advancing it into a receiving portion of theinstrument. The engaged working tool may include a machine readableindicium indicative of a working tool attribute. As such, the variouscharacteristics or parameters values that describe features associatedwith the particular engaged working tool may be embodied as a workingtool attribute stored at the working tool itself via the attachedmachine readable indicium or retrievable in association therewith.

The method 600 may also include receiving 604, based on the engaging, aworking tool attribute. For example, an identifier may be received at acorresponding machine readable indicia reader. In this regard, thevarious characteristics or parameters values that describe featuresassociated with the particular engaged working tool may be read from orotherwise transferred from the machine readable indicium of the engagedworking tool. The method 600 may further include operating 606 adisplacement measuring apparatus operatively associated with theinstrument. In some instances, the displacement measuring apparatus maybe disposed in corresponding relation to the working tool to measuredisplacement of the working tool relative to an axis along which theworking tool is advanced during use. In other instances, thedisplacement measuring apparatus may be embodied by various othersensors of the instrument that measure data for use in determining oneor more operating conditions of the instrument.

The method 600 may further include providing 608 an output responsive tothe received identifier. In this regard, the instrument 106 may bedisposed remote from a controller or other communications and/or displaydevice configured to indicate information in relation to the instrument.

As noted above, the foregoing functionality and system for monitoring aninstrument with a working tool engaged thereby may be embodied by anynumber of instruments and corresponding working tools. According to oneembodiment, the instrument 106 may be embodied by a drill that includesa drill bit penetration measuring system for determining, with respectto a reference point, a depth of penetration of a leading edge of adrill bit in a bore. In turn, the working tool 102 may be embodied by adrill bit that may be disposed for engagement with a chuck of the drill.In this regard, the drill bit may include a machine readable indiciumindicative of a drill bit attribute such that the drill may receive anidentifier of the drill bit at a corresponding machine readable indiciareader upon the receipt of the drill bit by the drill. As such, theforegoing disclosed functionalities of the system 100 may be configuredfor use with such drill and corresponding drill bit and accompanyingmeasurement systems, according to embodiments described below.

As may be appreciated, certain aspects of the present disclosure mayinvolve storage and manipulation of data in a database structure (e.g.,to maintain information regarding specific working tools, operations,uses, etc.). It is presently contemplated that at least portions of suchdata may be advantageously provided in connection with a decentralizedcryptographic distributed ledger such as blockchain. In this regard,blockchain technology may be used to capture and store data that isdescribed herein. For instance, any data described herein may beprovisioned in a blockchain such that transactions involving certainworking tools may be stored and accessible for later review.Furthermore, use of blockchain technology may allow for leveraging offeatures facilitated by blockchain technologies such as smart contractsor the like. For instance, upon use of a working tool, the expenditureof the working tool may be noted in the blockchain, which may triggerreorder of a further working tool for a facility. Alternatively, if asupply level of working tools drops to a predetermined level, a smartcontract built into the blockchain may be triggered to reorder workingtools. Further still, certain information (e.g., provided via a hospitalinformation system (HIS)) may be monitored and working tools may beautomatically ordered in advance of a procedure. Such ordering may befacilitated using a blockchain. In this regard, the blockchain may be apublic or private register. For instance, if information containingpersonally identifying information is provided, the blockchain may beprivate such that such information may be maintained in confidence.

In this regard, turning next to FIGS. 7-18 , where like numeralsindicate like elements throughout, there is shown another embodiment ofthe system for monitoring an instrument with a working tool engagedthereby in relation to a drill bit penetration measurement systemgenerally designated 700, and hereinafter referred to as the“measurement system” 700, in accordance with the present invention. Themeasurement system 700 is for determining, with respect to a referencepoint (not shown), a depth of penetration of a leading edge 702 a of arotating drill bit 702 in a bore when the leading edge 702 a of thedrill bit 702 passes from a first medium having a first density to asecond medium adjacent the first medium and having a second density. Thedrill bit 702 is rotatably driven by a drive 704 in a drill housing 706of any typical well known surgical drill. In this regard and as may beappreciated below, a measurement system 700 may be provided with anexisting surgical drill as a retrofit. In a further embodiment describedin greater detail below, a measurement system 1000 may be provided thatis at least partially integrated into a drill 1002 as shown, forexample, in FIGS. 16A-16C.

Preferably the first and second media are a hard outer cortex 802 and amedium such as air or other anatomical structure (not shown) surroundingthe outer surface of the cortical bone 804 and the bore is either abicortical bore 806 or a unicortical bore 808 being drilled in thecortical bone 804 (See FIGS. 8A-8B). However, those skilled in the artwill understand from the present disclosure that the first and secondmedia can be the hard outer cortex 802 and the soft inner medullarylayer 809 of the cortical bone 804 or any adjacent media of differentdensity without departing from the scope of the invention. The artisanwill also understand that the reference point is a fixed point relativeto which the displacement of the leading edge 702 a of the drill bit 702is measured and may correspond to an initial position of the measurementsystem 700 or portion thereof as further discussed below.

For example, as shown in FIGS. 8A and 8B, the bony structure of thehuman anatomy consists mainly of cortical bone 804, including hard outercortex 802 and soft inner medullary layer 809. Following traumaticinjury, plate and screw placement is critical for adequate repair of afractured bone. Improper drilling lengths could lead to deviceinstability, damage to anatomic structures, or device failure.

As shown in FIG. 8A, when using the rotating drill bit 702 to form abicortical bore 806 through the cortical bone 804, the rotating drillbit 702 passes through a first portion 802 a of the hard outer cortex802, a soft non-resistant medullary layer 809, and a second portion 802b of the hard outer cortex 802.

As shown in FIG. 8B, when using the rotating drill bit 702 to form theunicortical bore 808 through the cortical bone 804, the rotating drillbit 702 passes through an entry point 810 a of the hard outer cortex 802and an exit point 810 b of the hard outer cortex 802 without penetratingthe soft non-resistant medullary layer 809. As such, with reference toFIG. 2 , the measurement system 700 comprises a drill bit displacementmeasurement assembly 708, a drill bit load measurement assembly 710, anda controller assembly 712. The displacement measurement assembly 708 isconnected to the drill housing 706. The connection can be made by avariety of well-known mounting methods such as a mount that clamps tothe displacement measurement assembly 708 and is attached to the drillhousing 706 by one or more threaded fasteners. Alternative methods suchas welding or adhesive bonding could also be used. The displacementmeasurement assembly 708 has a first sensor 714 that outputs a firstsignal 714 s representative of a displacement, with respect to thereference point, of the leading edge 702 a of the drill bit 702 in thebore being drilled. The displacement measurement assembly 708 preferablyhas an extension 716 that is displaceable along a longitudinal axis. Theextension 716 has a distal end 716 a that can be placed in registry withthe reference point when the leading edge 702 a of the drill bit 702 ispositioned at the entry point, such as the entry point 806 a of thebicortical bore 806 or the entry point 810 a of the unicortical bore 808shown in FIGS. 80A-8B and maintained in registry with the referencepoint throughout the drilling process. The reference point can be anyanatomical structure proximal to the desired location of the bore to bedrilled. The extension 716 has a proximal end 716 b that is attached tothe first sensor 708. Preferably the sensor 708 is a linear variabledifferential displacement transducer (“LVDT”).

Referring to FIGS. 9A and 9B, the drill bit load measurement assembly710 comprises a housing 718, a thrust assembly 720 about which thehousing 718 is rotatable, a drill chuck 722 and a second sensor 724. Thehousing 718 has an axis of rotation 726 and is removably connected tothe drive 704 for rotation thereby. Preferably, the housing 718 has agenerally cylindrical-like shape and has a chamber 728 extending thelength thereof for containing a portion of the thrust assembly 720 and aportion of the drill chuck 722. Preferably, but not necessarily, thehousing 718 also has a proximal end 718 a with an outer diameter sizedfor being secured in a drive chuck 730 of the drive 704. Those skilledin the art will understand from this disclosure that the drive chuck 730can be any well-known surgical drill chuck through which surgicalinstruments are insertable.

The thrust assembly 720 is preferably a tube 732 with a bore 734therethrough. The bore 734 has a piston 736 moveable therein. The tube732 has a first portion 732 a having a first outer diameter and a secondportion 132 b having a second outer diameter less than the first outerdiameter. Similarly, the bore 734 has a first portion 734 a having afirst inner diameter and a second portion 734 b having a second innerdiameter less than the first inner diameter. Preferably, the piston 736is in the first portion 734 a of the bore 734. The second portion 132 bof the tube 720 extends beyond the proximal end 718 a of the housing718. The thrust assembly 720 is connected to the housing 718 by a firstbearing 738 and to the drill chuck 722 by a second bearing 740,preferably connected to the piston 736. Preferably, the first and secondbearings 738, 740 are thrust bearings suitable for use in a surgicalenvironment. Alternatively, the first and second bearings 738, 740 couldbe any device that permits the housing 718 and the drill chuck 722 torotate with respect to the thrust assembly 720 and allows a forceapplied to the leading edge 702 a of the drill bit 702 to be transferredto the thrust assembly 720. Preferably, but not necessarily, the thrustassembly 720 also is journaled with the housing 718 by a third bearing742.

The drill chuck 722 is connected to the housing 718 for rotationtherewith and to the thrust assembly 720 for rotation with respectthereto. The drill chuck 722 is moveable in translation along the axisof rotation 726 of the housing 718. Preferably, the drill chuck 722 is aconventional surgical drill chuck having a proximal end 722 a within thechamber 728 of the housing 718. The drill chuck is connected to thehousing 718 by a tab 744 extending radially outwardly from the proximalend 722 a of the drill chuck 722. The tab 744 extends into acorresponding slot 746 in the housing and is moveable therein intranslation along the axis of rotation 726 of the housing 718.Preferably, but not necessarily, the drill chuck 722 has diametricallyopposed tabs 744. Those of ordinary skill in the art will understandfrom the present disclosure that tabs 744 can be removably attached tothe drill chuck 722 by a threaded fastener (not shown) to facilitateinsertion of the proximal end 722 a of the drill chuck into the housing718. The proximal end 722 a of the drill chuck 722 additionally has aprojection 748 that extends into the bore 734 of the thrust assembly 720and is connected by the second bearing 740 to the piston of the thrustassembly 720.

The second sensor 724 is connected to the thrust assembly 720 andoutputs a second signal 724 s representative of a force applied to theleading edge 702 a of the drill bit 702. As shown in FIG. 9A, in onepreferred embodiment of the present invention, the second sensor 724 isa hydraulic pressure transducer and a portion of the bore 734 forms ahydraulic chamber 750 connecting the second sensor 724 with the piston736. As shown in FIG. 10A, in another preferred embodiment of thepresent invention, the second sensor 724′ is a load cell, such as apiezo-electric device, adjacent the piston 736 and a portion of the bore734 forms a conduit 750′ through which passes an electrical conductor752 connecting the piezo-electric device to the controller assembly 712.

Referring to FIGS. 7 and 11-12 , the controller assembly 712 is inelectrical communication with the first sensor 714 and the second sensor724. In an embodiment, the controller assembly 712 has a controllerhousing 754 integral with the drill housing 706. However, with furtherreference to FIG. 15A, the controller housing 754 may also be providedas a remote unit. The controller assembly 712 includes a processor 756in electrical communication with the first and second sensors 714, 724and with a mode selector 758 having a mode selector switch 760 and adisplay 762 having a reset button 761. The display 762, the reset button761 and the mode selector switch 760 may be mounted in a panel 764 ofthe controller housing 754. Alternatively, the display 762 or the resetbutton 761 or the mode selector 760 or any combination thereof could beseparately housed in the remote control unit that communicates with thefirst and second sensors 714, 724 by a wired or wireless link. Thedisplay 762 is for indicating the measured displacement of the leadingedge 702 a of the drill bit 702 to the user. The display 762 iscontrolled by the processor 756. The display 762 may continuouslyindicate the changing displacement of the leading edge 702 a of thedrill bit 702 during the drilling of a bore and may also indicate thelength of the bore at the when the drill bit 702 passes from one mediumto another. In another embodiment, the remote unit may include a remotecontroller operable to provide an output indicative of a drill bitoperating condition, as discussed in greater detail below.

For instance, with continued reference to FIGS. 15A and 15B, the display762 may be a touch sensitive display. The display 762 may include anindication of a bore diameter 766, the drill speed 768, a drilldirection 770, and a screw size indicator 772. The display 762 may alsoinclude patient information 774. The controller assembly 712 may includea port 776 for engagement of a wired plug connection 778 with the drill1002. In other embodiments, the drill 1002 may include a wirelessconnection to facilitate the foregoing. In this regard, the drill 1002may be connected to the controller assembly 712 to supply power to thedrill 1002 and communicate data between the drill 1002 and thecontroller assembly 712.

Referring to FIGS. 7, 11-12, 13A, 13B, and 13C, the processor 756 isconfigured to operate in a first mode for drill bit penetrationmeasurement in unicortical bore drilling. In the first mode theprocessor 756 is configured to output a third signal 756 s ₁representative of the depth of penetration of the leading edge 702 a ofthe drill bit 702 when the leading edge 702 a of the drill bit 702passes from the first medium to the second medium. The third signal 756s ₁ is based on the first and second signals 714 s, 724 s. Preferably,the third signal 756 s ₁ is output upon a first occurrence 780 of asecond time derivative of the first signal 714 s being greater than zeroand a first time derivative of the second signal 724 s being less thanzero. In other words, a positive acceleration of the drill bit 702 and aconcurrent reduction in the force applies to the leading edge 702 a ofthe drill bit 702 trigger the first occurrence 780. At the time of thefirst occurrence 780, the third signal 756 s ₁ corresponds to the lengthof the unicortical drill path.

Preferably, but not necessarily, the processor 756 is also configured tooperate in a second mode for drill bit penetration measurement inbicortical bore drilling and the mode selector 758 and mode selectorswitch 760 are for selecting between the first and second modes. Thesecond mode of operation is directed to the case where the first mediumis the cortical bone 802 surrounded by a second medium, such as the airor tissue surrounding the outer surface of the cortical bone 802, andthe first medium encloses a third medium, such as the soft medullarylayer 809, having a third density. In the second mode, the processor 756is configured to output the third signal 756 s ₂ in response to a secondoccurrence 782 of the second time derivative of the first signal 714 sbeing greater than zero and the first time derivative of the secondsignal 724 s being less than zero and corresponds to the length of thebicortical drill path. Accordingly, the third signal 756 s ₂ is outputafter the second time the drill bit 702 accelerates with a concurrentreduction in the force applied to the leading edge 702 a of the drillbit 702.

Additionally or alternatively, the third signal 756 s (collectivelyreferring to 756 s ₁ and 756 s ₂ referenced above) may be at leastpartially based on additional parameters other than the first signal 714s and second signal 724 s. For instance, in at least some embodiments,the third signal 756 s may be at least partially based on a parameterassociated with the rotation of the drill bit 702. For instance, thespeed of the drive 704 turning the drill bit 702, the torque applied tothe drill bit 702 by the drive 704, or another appropriate parameterregarding the rotation of the bit 702 may be utilized in outputting thethird signal 756 s. Further still, parameters such as the diameter ofthe drill bit 702, the bone to be drilled, or other appropriateparameters may be utilized in determining the third signal 756 s.

Furthermore, the generation of the third signal 756 s may at leastpartially be customized based on the patient. In this regard,information regarding the patient may be provided to the controllerassembly 712 and utilized by the processor 756 in determining the thirdsignal 756 s. For instance, a patient's age, sex, and/or otherdemographic information may be provided. As may be appreciated, thedemographic data of the patient may provide a correlation to expectedbone density or other parameter regarding an expected property of thepatient's anatomy based on the demographic data of the patient. In thisregard, the demographic data may be used to correlate an expectedparameter associated with the patient's anatomy (e.g., bone density)that may be used as a factor in generation of the third signal 756 s. Inaddition, direct measurement of an anatomical parameter for a givenpatient may be provided directly to the controller assembly 712, therebypotentially eliminating the need to estimate the parameter based ondemographic data.

Referring to FIG. 14 , there is shown a block diagram of a firstpreferred method for determining, with respect to a reference point, thedepth of penetration of the leading edge 702 a of a rotating drill bit702 in a bore when the leading edge 702 a of the drill bit 702transitions from a first medium having a first density, such as the hardouter cortex 802 of a cortical bone 804, to a second adjacent mediumhaving a second density, such air or tissue surrounding the outersurface of the cortical bone 804 (FIG. 8B).

An initial position of the leading edge 702 a of the drill bit 702relative to the reference point is established (Step 1405). The initialposition may be established by placing the leading edge 702 a of thedrill bit 702 against the outer surface of the cortical bone to bedrilled and by extending the distal end 716 a of the extension 716 ofthe displacement measurement assembly 708 to the reference point, suchas an anatomical structure proximal to the desired location of the boreto be drilled. As will be appreciated in the discussion of theembodiments below, the reference point may also be established by abushing member of a drill bit assembly that is engaged with adisplacement sensing arm of a displacement sensor. With the leading edge702 a of the drill bit 702 and the measurement system reference point inthe above positions (i.e., aligned at a surface of the medium to bedrilled), the measured displacement of the drill bit 702 is set to zeroby pressing the reset button 761. Upon commencement of drilling, a firstsignal representing the depth of penetration of the leading edge 702 aof the rotating drill bit 702 in the bore is output (Step 1410). Asecond signal representing a force applied to the leading edge of thedrill bit is output (Step 1415). A third signal based on the first andsecond signals and representative of the depth of penetration of theleading edge of the drill bit when the leading edge of the drill bitpasses from the first medium to the second medium is output (Step 1420).Preferably, the third signal is output when the second time derivativeof the first signal is greater than zero and a first time derivative ofthe second signal is less than zero.

The third signal may be accompanied by an alert that may be perceivableby a user of the drill. As such, upon determination that the drill haspassed through the bone, the alert may provide feedback to the user thatthe bone has been drilled through. As such, the alert may be an auditoryalert such as a tone or the like. In another embodiment, the alert maybe a change in the speed of the motor of the drill. For instance, thedrill may be slowed such that the user may be alerted to the fact thatthe drill has passed through the bone. Further still, the drill may bestopped at the occurrence of the third signal. It may be appreciatedthat any other user perceivable alert may be provided including, forexample, a visual, tactic, or other type of user perceivable feedback.

Notably, the components used to construct the present invention mayconsist of a variety of materials that are customarily used in themanufacture of surgical drills. One having ordinary skill in the artwill readily appreciate the materials that most desirably may be used toconstruct the present invention. In a preferred embodiment, however, thedrilling mechanism, drill bit displacement measurement assembly, thedrill bit load measurement assembly and the structural elements of thecontroller assembly may be constructed of a combination of polymericmaterials, polymers, and stainless steel.

Furthermore, it may be appreciated that the spacing of the extension 716of the displacement sensor 708 from the drill bit 702 may introduce thepotential for errors or other disadvantages in determining thedisplacement of the drill bit 702 relative to the reference point. Forinstance, as the extension 716 may contact a structure that is offsetfrom the contact point between the leading edge 702 a of the drill bit702 and the medium to be drilled. Accordingly, any movement between thestructure contacted by the extension 716 and the medium to be drilledmay be falsely registered as relative movement of the drill 702 withrespect to the reference point. Furthermore, there may not be a rigidstructure to contact adjacent to the medium to be drilled, leading todisplacement of the structure contacted by the extension 716 such as inthe case where the extension 716 may contact soft tissue adjacent to themedium to be drilled given the offset from the location to be drilled.Furthermore, the offset nature of the extension 110 relative to thecontact between the drill bit 702 and the medium to be drilled may leadto other complications such as having to expose a greater surface of themedium to be drilled, which may adversely affect patient outcomes.

As such, an improved embodiment of a drill with an improved displacementsensor including a displacement sensing arm that extends from the drillmay be provided. For example, such a displacement sensing arm may beprovided that may coordinate with a bushing member of a drill bitassembly that may be used with the drill. In this regard, the bushingmay move along the drill bit in a direction corresponding to the axis ofrotation of the drill bit. Upon engagement of the bushing and thedisplacement sensing arm, the bushing and displacement sensing arm mayundergo corresponding movement. As such, the bushing may be disposed incontact with the medium to be drilled when the leading edge of the drillbit is in contact with the medium. As such, a reference point may beestablished when the bushing and leading edge of the drill bit are bothin contact with the medium to be drilled. As the bushing is locatedadjacent to (e.g., partially or fully surrounding) the drill bit, thebushing may facilitate contact with the medium at or very near thelocation to be drilled prior to creating a bore as described above. Inthis regard, the reference point may be more accurately maintained asthe bushing may contact at least a portion of a periphery of the borecreated in the medium drilled. That is, the bushing may remain inintimate contact with the medium to be drilled adjacent to the borecreated. This may prevent false displacement readings attributable tothe foregoing problems associated with an offset extension 110.Furthermore, the amount of contact of the drill may be localized at thelocation to be drilled, thus allowing for potentially less intrusionwhen performing drilling operations.

For example, with additional reference to FIGS. 16A-16C and 17 , anembodiment of a drill 1002 comprising an embodiment of a measurementsystem 1000 is shown. The drill 1002 may be adapted for use with a drillbit assembly 1004 that may include a bushing 1006. The drill 1002 mayintegrally comprise at least some components of the measurement system1000 to facilitate operation of the measurement system 1000 inconnection with the drill 1002. For example, at least a portion of adisplacement sensor 1008 may be integrated into a housing 706 of thedrill 1002. In this regard, the displacement sensor 1008 may include adepth sensing arm 1010 that is specifically adapted for engagement witha bushing 1006 of a drill bit assembly 1004 that may be engaged by achuck 1014 of the drill 1002.

In this regard, the depth sensing arm 1010 may be used to establish areference point from which displacement of the drill bit 702 may bemeasured as described above. In this regard, as follows herein, ageneral description of the features and operation of the drill 1002 usedin conjunction with the drill bit assembly 1004 is provided.

As may be appreciated in FIGS. 16A-16C, the displacement sensor 1008 mayinclude a depth sensing arm 1010 that may extend from the drill housing706. For example, the depth sensing arm 1010 may extend distally (e.g.,from a distal face 1016 of the drill housing 706) in a directioncorresponding with the direction in which the drill bit 702 extends froma chuck 1014 of the drill 1002. At least a portion of the displacementsensing arm 1010 may extend from the drill housing 706 parallel to anaxis of rotation 726 of the drill 1002. The depth sensing arm 1010 mayalso include a distal portion 1018 that is adapted to engage the bushing1006 provided with the drill bit assembly 1004. As used herein, distalmay correspond to a direction from the drill 1002 toward the leadingedge 702 a of the drill bit 702 and proximal may correspond to adirection from the leading edge 702 a of the drill bit 702 toward thedrill 1002. In this regard, at least a portion of the depth sensing arm1010 (e.g., the distal portion 1018) may be adapted to engage thebushing 1006 of the drill bit assembly 1004 as will be described in moredetail below. In any regard, at least a portion of the depth sensing arm1010 may extend into the housing 706. With further reference to FIG. 17, the housing 706 may contain a coil 1020. As such, a proximal end 1022of the displacement sensing arm 1010 may interface with the coil 1020 ofthe displacement sensor 1008 that may be disposed within the drillhousing 706.

Specifically, in FIG. 17 , the depth sensing arm 1010 is shown in aretracted position relative to the drill bit 702. As such, thisretracted position shown in FIG. 17 may occur when the drill bit 702 isadvanced relative to the bushing 1006 during drilling. In this regard,the proximal end 1022 of the displacement sensing arm 1010 is disposedwithin the coil 1020 of the displacement sensor 1008. Accordingly, thedisplacement sensor 1008 may comprise an LVDT sensor as described abovethat is adapted to sense the position of a core 1024 relative to thecoil 1020. The displacement sensing arm 1010 may incorporate the core1024 at the proximal end 1022 thereof. Accordingly, as the proximal end1022 of the displacement sensing arm 1010 is moved relative to the coil1020, the location of the core 1024 may be determined to provide anoutput corresponding to the position of the core 1024, and in turn thedisplacement sensing arm 1010 relative to the drill housing 706. Thatis, the depth sensing arm 1010 may be displaceable relative to the coil1010 such that the displacement sensor 1008 may be operable to sense achange in position of the depth sensing arm 1010 relative to the drillhousing 706 and output a measure of the displacement that may be used asdescribed above in determining a depth of a bore. In an embodiment, thetotal measurable travel of the core 1024 relative to the coil 1020 maybe at least about 2.5 in (6.4 cm). Furthermore, the resolution of theoutput of the displacement sensor 1008 may be about 0.1% (e.g., about0.002 inches (0.06 mm) for a sensor having a total measurable travel of2.5 inches).

While a LVDT displacement sensor is shown and described in relation tothe drill 1002 shown in the accompanying figures, it may be appreciatedthat other types of displacement sensors may be provided. For instance,the sensor may provide for the absolute or relative measurement of theposition of the distal end 1022 of the displacement sensing arm 1010 toprovide a displacement measure. For instance, in another embodiment, anoptical displacement sensor may be provided. Other types of displacementsensors are also contemplated such as, for example, a capacitivedisplacement sensor, ultrasonic sensors, Hall effect sensors, or anyother sensors known in the art capable of outputting an absolute orrelative position measure.

In an embodiment, the coil 1020 may define a passage 1026 extending atleast partially through the housing 706. Specifically, the passage 1026may extend from a proximal face 1028 of the housing 706 to the distalface 1016 of the housing 706. That is, the passage 1026 may extendentirely though the housing 706. An end cap 1030 may be provided that isoperable to close the proximal end of the passage 1026 at the proximalface 1028 of the drill housing 706. Furthermore, a biasing member 1032(e.g., a coil spring) may be provided in the passageway 1026 at aproximal end thereof. The biasing member 1032 may be provided betweenthe end cap 1030 and the proximal end 1022 of the displacement sensingarm 1010. In this regard, the biasing member 1032 may act on theproximal end 1022 of the displacement sensing arm 1010 to bias thedisplacement sensing arm 1010 distally relative to the passage 1026 anddrill housing 706.

As such, the displacement sensing arm 1010 may include features thatselectively prevent ejection of the displacement sensing arm 1010 fromthe distal end of the passage 1026. For example, the displacementsensing arm 1010 may include at least one flat 1034 that extends along aportion of the arm 1010. At the proximal and distal extents of the flat1034, the displacement sensing arm 1010 may include shoulders 1036 thatproject from the flats 1034 (best seen at the distal portion 1018 inFIG. 16B and at the proximal portion 1022 in FIG. 17 ). As such, at theproximal opening of the passage 1026, a selectively displaceable stop1038 may be disposed relative to the flat 1034 such that the flat 1034may move relative to the stop 1038, but interfere with the shoulder 1036defined in the displacement sensing arm 1010 to prevent passage of theshoulder 1036 beyond the stop 1038. In this regard, the length of thedisplacement sensing arm 1010 along which the flat 1034 extends may bemoveable relative to the stop 1038, and the stop 1038 may limit proximaland distal movement of the displacement sensing arm 1010 beyond the stop1038.

However, the stop 1038 may be displaceable upon depressing, for example,a button 1040 provided on an exterior of the housing 706. Thus, upondepressing the button 1040, the stop 1038 may be displaced away from thedisplacement sensing arm 1010 to allow the shoulder 1036 to passdistally from the distal end of the passage 1026 such that thedisplacement sensing arm 1010 may be removed entirely from the passage1026. The distal end of the flats 1038 may include a detent 1042 thatmay be engageable with the stop 1038 so as to maintain the displacementsensing arm 1010 in a proximally disposed, retracted position relativeto the housing (e.g., as shown in FIG. 17 ). Once the button 1040 isdepressed and released, the detent 1042 at the proximal end of the flat1034 of the displacement sensing arm 1010 may be released by the stop1038 and the displacement sensing arm 1010 may move proximally (e.g.,under influence of the biasing member 1032). The displacement sensingarm 1010 may move proximally until the shoulder 1036 at the distal endof the flat 1034 are engaged to prevent further distal movement of thedisplacement sensing arm 1010. Accordingly, the displacement sensing arm1010 may be retained in a retracted position, released to be moveablerelative to and biased proximally with respect to the housing 706, andremovable altogether from the housing 706.

In the latter regard, removal of the displacement sensing arm 1010 andbiasing member 1032 from the passage 1026 may allow for separatecleaning of those members. Additionally, removal of the end cap 1030 mayallow for a cleaning apparatus to be passed through the full length ofthe passage 1026 to facilitate cleaning thereof.

As referenced above, the distal portion 1018 of the displacement sensingarm 1010 may be adapted to engage a drill bit assembly 1004 that iscorrespondingly adapted for use with the drill 1002. For instance, asshown in FIGS. 16A-16C and FIG. 17 , the displacement sensing arm 1010may generally be linear along the proximal portion 1022 of thedisplacement sensing arm 1010. In this regard, the proximal portion 1022may be adapted to be collinear with the passage 1026 and moveable withinthe passage 1026. Furthermore, the distal portion 1018 of thedisplacement sensing arm 1010 (e.g., the portion distal to the linearportion of the displacement sensing arm 1010) may extend from the linearportion of the displacement sensing arm 1010 toward the drill bitassembly 1004 that may be engaged by the chuck 1014 of the drill 1002.In this regard, the linear portion of the displacement sensing arm 1010may be substantially parallel to and offset from the axis of rotation726. The distal portion 1018 may extend from the linear portion in adirection corresponding with the offset such that the distal portion10184 extends toward the drill bit assembly 1004. This may facilitateengagement between the displacement sensing arm 1010 and the bushing1006 of the drill bit assembly 1004. As shown, in FIGS. 16A-16C and 17 ,the distal portion 1018 may be an at least partially arcuate memberextending along a radius of curvature toward the drill bit assembly1004. However, the distal portion 1018 may be shaped differently (e.g.,the distal portion 1018 may be a linear portion extending at an angle orperpendicularly from the proximal 1022 toward the drill bit assembly1004).

For instance, with further reference to FIG. 18 , a schematic sectionview of a drill bit 702 that has been advanced into a medium 1100 isshown. The bushing 1006 may be disposed about the drill bit 702. Assuch, the bushing 1006 may be disposed about the periphery of a bore1102 created upon advancement of the drill bit 702 into the medium 1100.That is, the bushing 1006 may remain in contact with the surface 1102 ofthe medium 1100 upon advancement of the drill bit 702 into the medium1100. In this regard, the bushing 1006 may include a reference surface1104 at a distal portion thereof. The reference surface 1104 may contactthe surface 1102 of the medium 1100 to be drilled. As such, prior toinitiation of the drilling when the leading edge 702 a of the drill bit702 is also in contact with the surface 1102, the displacement sensor1008 may be set to establish the reference point. Accordingly, as thedrill bit 702 is advanced, the reference surface 1104 may remain incontact with the surface 1102 of the medium 1100. The reference surface1104 may contact the surface 1102 about a periphery of a bore 1106. Inan embodiment, the reference surface 1104 may extend circumferentiallyabout a majority or substantially all of the drill bit 702 such that thereference surface 1104 may also extend circumferentially about amajority of or substantially all of the periphery of the bore 1106. Thedistally biased displacement sensing arm 1010 may act on the bushing1006 (e.g., by way of post 1044 received in hole 1048) to maintain thebushing 1006 in contact with the surface 1102. In any regard, thedisplacement (d) of the leading edge 702 a of the drill bit 702 relativeto the reference surface 1104 of the bushing 1006 may be measured uponcorresponding movement of the core 1024 at the proximal end 1022 of thedisplacement sensing arm 1010 relative to the coil 1020.

The foregoing description of the present invention has been presentedfor purposes of illustration and description. Furthermore, thedescription is not intended to limit the invention to the form disclosedherein. Consequently, variations and modifications commensurate with theabove teachings, and skill and knowledge of the relevant art, are withinthe scope of the present invention. The embodiments describedhereinabove are further intended to explain best modes known ofpracticing the invention and to enable others skilled in the art toutilize the invention in such, or other embodiments and with variousmodifications required by the particular application(s) or use(s) of thepresent invention. It is intended that the appended claims be construedto include alternative embodiments to the extent permitted by the priorart.

What is claimed is:
 1. A system for monitoring use of a working toolwith a powered surgical instrument, the system comprising: a poweredsurgical instrument comprising a drive motor; a working tool that isremovably engageable with the powered instrument, wherein the poweredinstrument is operable to drive the working tool when the working toolis engaged with the powered instrument to accomplish an operation, andwherein the working tool includes an identifier; a reader associatedwith the powered instrument and operative to read the identifier of theworking tool when the working tool is engaged with the poweredinstrument; a controller in operative communication with the reader thatis operative to receive information regarding the identifier andassociate the working tool with the powered instrument; and a sensorconfigured to measure at least one characteristic associated with theoperation of the working tool, wherein the controller is configured toreceive the at least one characteristic associated with the operation ofthe working tool, and wherein the controller is operative to process theinformation regarding the identifier and the at least one characteristicassociated with the operation of the working tool to provide an output.2. The system as set forth in claim 1, wherein the working toolcomprises a connection portion for selective engagement of the workingtool with the powered instrument, and the unique identifier is adjacentthe connector portion of the working tool.
 3. The system as set forth inclaim 2, wherein the powered instrument comprises an engagement portionthat engages the connection portion of the working tool and the readeris adjacent to the engagement portion such that the unique identifier isreadable by the reader when the working tool is engaged by theengagement portion of the powered instrument.
 4. The system as set forthin claim 1, wherein the controller is operable to generate the outputresponsive to receipt of the information regarding the uniqueidentifier.
 5. The system as set forth in claim 4, wherein the receiptof the information regarding the unique identifier is indicative ofengagement of the working tool with the powered instrument.
 6. Thesystem as set forth in claim 5, wherein the controller is operative tocontrol the drive motor, and wherein the controller disables the drivemotor until and unless the information regarding the unique identifieris received.
 7. The system as set forth in claim 1, wherein the uniqueidentifier is indicative of a working tool attribute.
 8. The system asset forth in claim 7, wherein the working tool attribute comprises atleast one of a working tool size, a working tool material, a workingtool weight, a working tool manufacturer, and a working tool serialnumber.
 9. The system as set forth in claim 1, wherein the sensor isconfigured to measure the displacement of the working tool relative toan axis along which the working tool is advanced during the operation.10. The system as set forth in claim 7, wherein the controller isoperative to determine an instrument operating condition and isoperative to provide the output responsive to the determination of theinstrument operating condition.
 11. The system as set forth in claim 10,wherein the instrument operating condition is at least partially basedon the working tool attribute.
 12. The system as set forth in claim 11,wherein the instrument operating condition is indicative of acondition-dependent status, the condition-dependent status correspondingto a physical condition of the instrument.
 13. The system as set forthin claim 12, wherein the working tool is one of a plurality of workingtools, each of the plurality of working tools being removably engageablewith the powered surgical instrument, and wherein the powered surgicalinstrument operating condition is indicative of an inventory-dependentstatus, the inventory-dependent status corresponding to engagement of asubset of the plurality of working tools with the instrument.
 14. Thesystem as set forth in claim 10, further comprising: a collection modulethat is configured to associate the instrument operating condition witha health history characteristic of a subject of a surgical operation,the health history characteristic comprising at least one of age,weight, sex, nationality, geographic location, medication history, anddisease history.
 15. The system as set forth in claim 1, wherein thecontroller is remotely disposed from the instrument, and wherein theinstrument further comprises: a transmitter for transmitting acommunications signal to the controller, the communications signalindicative of the information regarding the unique identifier.
 16. Thesystem as set forth in claim 1, wherein the unique identifier comprisesa radio frequency identification (RFID) tag.
 17. The system as set forthin claim 16, wherein the reader includes a radio frequencyidentification (RFID) reader.